Intrauterine AdhesionNCT03346317
Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
A study testing disposable balloon uterine stent, dried biological amnion graft and estradiol valerate tablets+dydrogesterone tablets in people with Intrauterine Adhesion, run by Beijing Obstetrics and Gynecology Hospital at 1 site in China.
Trial summary
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- disposable balloon uterine stent, dried biological amnion graft and estradiol valerate tablets+dydrogesterone tablets
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2017to 20 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age 20-40 years；
- previously diagnostic hysteroscopy confirmed adhesion score >5， according to the American Fertility Society （AFS）classification of IUA；
- complains of menstruation disorder and reproductive dysfunction；
- informed consent.
Who cannot join
- premature menopause,
- presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
- presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
- adhesions limited to the lower uterine cavity or the cervical canal.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Obstetrics and Gynecology Hospital，Capital Medical University
Beijing, Beijing Municipality, 100006
Liu Zhen, +8613718210767, fcyykyb@163.com
About this study
Official title: Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft for the Therapy of Uterine Adhesion
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon with amniotic products or estrogen can improve clinical outcomes? Therefore, this study was conducted.
Read the detailed description
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention
- Conditions
- Intrauterine Adhesion
- Being tested
- disposable balloon uterine stent, dried biological amnion graft, estradiol valerate tablets+dydrogesterone tablets
- Keywords
- Asherman syndrome, hysteroscopy, Uterine stent, Estrogen, Amnion, Hysteroscopic Adhesiolysis
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disposable balloon uterine stentDevice
The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter.
dried biological amnion graftProcedure or surgery
Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
estradiol valerate tablets+dydrogesterone tabletsDrug
Also called Progynova+dydrogesterone
oral estradiol valerate tablets+dydrogesterone tablets
| Study group | Role | What they receive |
|---|---|---|
| dried biological amnion graft | Experimental | patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis. Receives: Device: disposable balloon uterine stent; Procedure: dried biological amnion graft |
| estrogen | Experimental | patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. Receives: Device: disposable balloon uterine stent; Drug: estradiol valerate tablets+dydrogesterone tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adhesion information
Intrauterine adhesions under hysteroscopy
Measured: Within the first 3 months after surgery
Secondary outcomes (2)
Menstruation pattern
menstrual volume which was assessed by pictorial blood loss assessment chart
Measured: Within the first 3 months after surgery
The change of AFS score
The American Fertility Society ( AFS ) scoring system (1988 version). Scores of 1-4, 5-8, and 9-12 were mild, moderate, and severe adhesions, respectively.
Measured: Within the first 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start16 Nov 2017
- Primary completion16 May 2018 (estimated)
- Study completion20 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Obstetrics and Gynecology Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duan Hua, PhD, Study chair, Beijing Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346317
- Sponsor's protocol ID
- No.5-20171111
- Status last verified
- Nov 2017
- First submitted
- 14 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft for the Therapy of Uterine Adhesion
- ClinicalTrials.gov ID
- NCT03346317
- Acronym / sponsor ID
- No.5-20171111
- Conditions
- Intrauterine Adhesion
- Keywords
- Asherman syndrome, hysteroscopy, Uterine stent, Estrogen, Amnion, Hysteroscopic Adhesiolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Obstetrics and Gynecology HospitalUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 16 May 2018 (estimated)
- Study completion
- 20 May 2018 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon with amniotic products or estrogen can improve clinical outcomes? Therefore, this study was conducted.
Detailed description
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dried biological amnion graft | Experimental | Device: disposable balloon uterine stent, Procedure: dried biological amnion graftpatients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis. |
| estrogen | Experimental | Device: disposable balloon uterine stent, Drug: estradiol valerate tablets+dydrogesterone tabletspatients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 20-40 years；
- previously diagnostic hysteroscopy confirmed adhesion score >5， according to the American Fertility Society （AFS）classification of IUA；
- complains of menstruation disorder and reproductive dysfunction；
- informed consent.
Key exclusion criteria (4 listed)
- premature menopause,
- presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
- presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
- adhesions limited to the lower uterine cavity or the cervical canal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disposable balloon uterine stentThe disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter. | Device | dried biological amnion graft, estrogen |
| dried biological amnion graftUterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane | Procedure or surgery | dried biological amnion graft |
| estradiol valerate tablets+dydrogesterone tabletsAlso: Progynova+dydrogesteroneoral estradiol valerate tablets+dydrogesterone tablets | Drug | estrogen |
Primary outcome
Incidence of adhesion information
Time frame: Within the first 3 months after surgery
Intrauterine adhesions under hysteroscopy
2 secondary outcomes
Menstruation pattern
Time frame: Within the first 3 months after surgery
The change of AFS score
Time frame: Within the first 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duan Hua, PhD study chair
Beijing Obstetrics and Gynecology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing disposable balloon uterine stent, dried biological amnion graft and estradiol valerate tablets+dydrogesterone tablets in people with Intrauterine Adhesion, run by Beijing Obstetrics and Gynecology Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhu Ru, MD (13966636438, zhuru19790202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adhesion information (time frame: Within the first 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.